Identification of infants at birth is a critical issue for hospitals, birthing centers and other institutions where multiple births occur. With approximately 300,000 infants born worldwide each day, a large hospital may experience over one hundred new births each day. A large hospital may see as many as a hundred new infants each day. Correct identification of infants is essential to ensure that each mother travels home with her own child.
In the past infants have been identified by means of footprints. However, this is not a satisfactory method of identifying infants because there is no means of ensuring that a footprint is associated with a particular mother, other than placing a footprint in the mother's hospital records. Further, footprints of newborn infants are difficult to take and difficult to distinguish. Additionally, the footprints are useful for only a short period in identifying the infant and will not suffice as a permanent identification means.
Current identification technologies generally consist of attaching an identification device to the newborn with a matching device for the mother. Before an infant can be moved from the hospital, the devices are compared to ensure that only the mother of that infant can leave with the child. Such devices include the typical wrist bands or bracelets, which today are often electronically readable (see e.g., WO98/18111). In another variation, the mother wears a wrist band, but the infant has an umbilical clamp (see e.g., U.S. Pat. No. 5,484,060 and U.S. Pat. No. 5,608,382) and in yet another variation, the infant is actually marked with a semi-permanent ink (see e.g., GB2,273,266 and U.S. Pat. No. 5,484,060).
However, any device or external labeling means can be intentionally defeated, by changing the markings or electronic signature on the existing device, or by completely replacing the device with an appropriately marked device. Recently, it was discovered in the United States that two infants were switched at birth. Evidence strongly suggested that the switching was not accidental. Tragically, the switch was not discovered for several years and might not ever have been discovered absent a paternity contest involving one of the children. In its aftermath, the event leaves considerable consternation about how to cope with child custody issues, visitation rights, hospital liability, and an ongoing criminal investigation.
Public concern over this issue is significant. A recent market survey created by an academic institution was conducted on 200 expectant mothers to assess their interest in a service that would assure them that their infants had not been switched at birth. An overwhelming 85% of the respondents wanted such a service and would be willing to pay for it. Public concern has also reached the U.S. Congress. Proposed legislation entitled "The Infant Protection and Baby Switching Prevention Act of 1998" (H.R. 4680) has been introduced into the House of Representatives in an effort to require hospitals to address this problem. Unfortunately, no specific solution was recommended in the Act.
Therefore, although rare, infant switches do occur and with potentially devastating consequences. A failsafe method of uniquely identifying which infant belongs to which mother is urgently required. Such system should be tamper-proof, simple, easy, and cost effective. Furthermore, the ideal system would create a permanent record allowing for future identification of the child in the event of abduction or accident.
Genotyping has been used to identify paternity, and occasionally maternity, where contested, usually in a child support context. Genotyping has also been suggested and used after the fact where it is suspected that infants have been switched. See e.g., de Pancorbo M. M., et al., Newborn Identification: A Protocol Using Microsatellite DNA as an alternative to Footprinting, CLIN. CHIM. ACTA (1997) 263(1): 3342. However, to date no one has applied genotyping technology to systematically identify infants at birth and again at discharge to ensure that no switching has occurred and that the infant has been correctly paired with its birth mother. Furthermore, no one has provided a permanent storage mechanism for future identification purposes.
Such massive genotyping efforts have never been applied in a hospital setting and present significant logistical concerns. It would not suffice, for example, for a sample to be merely collected and later typed within the hospital environment because such a process is subject to the same labeling errors that currently exist with neonatal samples such as cord blood samples. See e.g., Heckman, Maria, et al., Quality Improvement Principles in Practice: The Reduction of Umbilical Cord-Blood Errors in the Labor and Delivery Suite; Interdisciplinary Performance Improvement, J. NURSING CARE QUALITY (1998) 3(12): 47 (noting that in the eight months prior to their process improvement efforts there were 18 mislabeled specimens out of 3,504 births--an error rate of 0.5%).